Standardisation is key to the success of adoption of new techniques and processes. If houses were not wired with copper wires providing power of a standard voltage through a predefined power outlet, Edison would not have been famous for his successful introduction of light bulbs. However, national or regional standards have been developed for power outlets and voltage but nobody is trying to get the responsible parties together to globally harmonise the voltage and power outlets. These kind of obvious standards have become a commodity and when travelling abroad, everybody uses adaptors that make the connection between regional power outlets and voltages.

How come that in the age of modern technology and quick communication we are still aiming at global standards? Should we be less dogmatic about global standards? Should we focus more on adaptors? Or electronic and automated adaptors that allow transfer of information from sender to recipient and vice versa? This is not limited to industry-to-agency transfer, but is also applicable to transfers between CROs and sponsor and between various applications within a company, such as, but not limited to, SAP, eDMS, eTMF, eSubmission, RIM, LIMS, SPL, electronic health records, electronic data capture and electronic forms.

Come and learn about the benefits and constraints associated with the various topic-related processes and contribute to answering the question whether standardisation is a blessing or a curse.

Attendees should make reservations as soon as possible using the promotional code DIA14110. DIA rate is guaranteed until 1 November 2014, or until room block is filled. After this rooms are subject to availability and prices may vary.

Agenda

Tutorials
Monday, Dec 01, 2014

Technology solutions for managing electronic Trial Master File (eTMF) documents are now established in many sponsors and contract research organisations. However, companies often experience challenges as they begin to implement solutions, sometimes several years later! This tutorial will provide attendees with an opportunity to discuss some of the more challenging aspects of eTMF implementation. Through instructor-facilitated discussions, guidance will be provided in a wide range of relevant topics.

9:00AM - 5:00PM (Central Europe Standard Time)

02 - UNDERSTANDING THE IMPACT OF IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP) ON PROCESSES, DATA PROVISION, GOVERNANCE AND IT ARCHITECTURE

The tutorial will give insight in the following areas:

Background of the IDMP standards and legislation

Structure and contents of the IDMP standards

Typical data mapping activities and results

IT architecture and application consequences

Specific areas of attention include clinical particulars and reporting of consistency of product information

Standardisation is becoming one of the most critical topics as our industry seeks to reduce costs, encourage harmonisation and improve efficiency. Our keynote speakers will bring us up-to-date with some key developments in this space for electronic document management and challenge our thinking right at the outset of our conference. Our speakers will cover standardisation developments for trial master files, regulatory submissions, IDMP and telematics, to name but a few!

Over the past 30 years we have shifted from information management on paper to digital information management using computers. However, until now, many processes are still based on paper thinking. Often we do not fully trust the automated processes, even though the systems have proven to do jobs as intended. People still tend to exchange information through e-mail, work outside validated systems and try to apply shortcuts in electronic processes. This session will explain more about why systems should be perceived as reliable, how data can be considered authentic and how to achieve that true perception by the users.

The session will focus on a review of the electronic document management for regulated documents of the Trial Master File (TMF), the Pharmacovigilance System Masterfile (PSMF), and during Pharmacovigilance lifecycle management. We will identify the individual documents required, their structure and content, and try to highlight the possibilities for automated information management.

Speaker(s):

Moving from an On-Premise to a Cloud-Based eDMS for Regulated Documents and eTMF- Part 2
Benoit Poupin
Director IT Regulatory and CMOIpsen, France

Several new standards for the transmission of structured regulatory information are being implemented over the course of the next two to four years. While the deadline for EVMPD is approaching fast, the preparation for IDMP is starting in parallel. And ten years after the introduction of the eCTD standard the development of the Next Major Version v4.0 is reaching ICH Step 2 and opens now for public consultation. All these new requirements will require flexible and scalable technical solutions to handle the transition from existing standards.

Karen Roy, MPharm
Global Business Development DirectorPhlexglobal Ltd, United Kingdom

An electronic Trial Master File (eTMF) is not just a piece of technology, it is all about getting efficient and effective processes and workflows in place to ensure that the eTMF is contemporaneous and ready for inspection at any time. This session will take you through implementation, through dealing with CROs and ending up focussing on inspections.

The legislative deadline of July 2016 for implementation of the International Organisation for Standards (ISO) standards for Identification of Medicinal Products (IDMP) is rapidly approaching. The session will cover the current status and agency plans and expectations, the general position of industry regarding the ability and readiness to implement and an assessment from one company of their approach to assessment of the impact and preparing for implementation.

Speaker(s):

EU Agencies’ Plans and Preparation for the Implementation of IDMP
Thomas BalzerBfArM, Germany

The Document and Records Management (DRM) community of the DIA has been busy since 2009 in the formation and update of Reference Models (RM) for document and content management. The currently published editions for both the eDM and the Trial Master File (TMF) Reference Models are available on the DIA website – eDM Corner. To keep those models updated to reflect the transformation of business processes, many updates and extensions are being prepared to keep them relevant as well as to harmonise and include additional process threads.
The current state of both models (eDM & TMF) will be discussed, how they are interrelated and where they are being extended. This session will also include an overview of the model evolution and other industry standards development. A short synopsis of the recently released TMF Metrics Model and the annual TMF industry survey will be included.
Experts from the eDM RM Core Team and TMF RM Steering Committee will deliver hands-on practical advice about model adoptions; including an interactive TMF RM best practice discussion / Q&A session with attendees, which will drive TMF RM V3.0 activities.

Speaker(s):

Karen Roy, MPharm
Global Business Development DirectorPhlexglobal Ltd, United Kingdom

The nature of regulatory work is getting more complex as time goes on. Resources are constrained and new models are being employed to get the work done in a more efficient manner. This session will look at the challenges and opportunities being addressed currently including outsourcing, dossier content management and how to address process, technology and resource management.

In this session, participants will learn about the general concept of utilising information in the clinical development environment and how this concept is being put into practice by different organisations.

Ownership and control of electronic clinical trial data and documents is clearly defined in the regulations, whether it is the data (electronic data capture) or the documents (electronic investigator site file). However with the move to cloud-based systems, more and more sponsors are maintaining control of the systems, and therefore the access, meaning that the Investigators can no longer show their ownership. This extends from eSource to live trial systems to electronic archiving and is not in compliance to the Regulators requirements. In this session, the views and perspectives of FDA and EMA (via the Danish Health and Medicines Agency) will be provided.